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Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
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Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04
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Old 4th January 2018, 04:42 AM
cataltar

 
 
Total Posts: 1
Please Help! Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04

We are a company in Turkey with all QA system managed in Turkish. Our ISO 13485 and CE mark are registered by a Turkish NB. Based on their interpretation of clause 6.4 of MEDDEV 2.7.1 Rev 04, our NB insists that the evaluator must be a "medical doctor" per definition of "specialist" on dictionary for Medical English. More of it, they say the Ministry of Health urges them to make this adaptation.

I tried to reason with them by explaining/translating the clause: when it states "e.g.
specialist clinical expertise in the relevant medical specialty", it means a clinician is a possible person, not a requisite.

Please correct me if I am wrong or help me convince them if I am correct.
Many thanks!

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